summary

Certified Business Analyst and Domain Expert with 10 years of experience in the field. Strong proponent of Agile driven and lean development. 5 years in university teaching experience of undergraduate and graduate level in a prestigious US university.Specialized in complex analytical software including Regulatory Compliance, and Risk Management.

Domains involved in are  Healthcare Enterprise Applications (EMR, EHR, PMS), Medical Device software , Clinical Trial Management Systems (Drug and Device),  e-commerce projects etc.

 A strategist-cum-implementer with recognized proficiency in spearheading business to accomplish corporate plans & goals.

Functional Domain: Business Analysis, Analytics,  Stakeholder Management, Account Management, Product Management.

Industry: IT Software Development.

recent publication

Employee Turnover- Issues faced by small IT companies in Kolkata. Dr. Anirban Mukherjee et al.,  Personnel Today,Journal from National Institute of Personnel Management (NIPM), Oct-Dec 2014 Issue, Vol. XXXV- No 3. December 1, 2014. 

VISA

  • USA: B1/B2, valid till Oct, 2019
  • Australia: 457, valid till 2018.

PERSONAL DETAILS

  • Date of Birth: 7th June, 1977
  • Languages: Bengali, English, Hindi, Deutsch, Italian, Persian, Sanskrit
  • Interests: Regulatory Compliance, Training/Teaching, Literature, Music, Horse Riding

CERTIFICATIONS

  •  INTERNATIONAL INSTITUTE OF BUSINESS ANALYSIS (IIBA)-  CBAP (perusing)exam on Sep, 2015
  • PROJECT MANAGEMENT INSTITUTE (PMI) - PMP (perusing), exam on Aug, 2015
  • BRAINBENCH - Software Business Analysis, 90th percentile, Dec’ 2013
  • KRIGER INTERNATIONAL RESEARCH CENTER (KRC) AND  INTERNATIONAL BIOPHARMACEUTICAL ASSOCIATION (IBPA) - Clinical Data Management (GCPs such as GDMP, GLP, GDP, and GMP) Nov’ 2010.
  • HIPAA TRAINING INSTITUTE - HIPAA Privacy and Security Expert Nov’ 2010.
  • SAS - SAS Base, 99th percentile, 2009, SAS Advanced, 91th percentile, 2009
  • LAKHOTIA COMPUTER CENTREIS (LLC) - Diploma in RDBMS (Oracle8 with Dev.2000), 2004

HIGHLIGHTS

  • Honorary positions and awards from the US government for excellence in research and related field including multiple Presidential citations.
  • 24 research publications, 2 seminal patents, 60% royalty of BBIC chip patent with ORNL, US for a certain nanobot
  • Spot award in Globallogic Inc..
  • Best Graduate Teaching Associate (Fall, 2006) University of Tennessee, TN, USA
  • IELTS (Academic) - 8 (2014), GRE- 1550/1600, TOEFL-300/300 (2004)
  • 1st class 1st in M.Sc (2002) Bhopal University, India
  • Gold medal and scholarship for academic excellence (1997), K. N. College, India
  • Winner, KAMAGATA CUP, West Bengal State Karate Championship, India (1994, 1995 and 1996)

Skills

Skills

Business Analysis Tools/ Techniques

System Engineering Concepts: Process Flow Diagrams (PFDs), Work Flow Diagrams, Activity Diagrams, cross functional Sequence Diagrams/swim lanes, Models, Wireframes, Prototypes, ERDs, Use Case, User Story. UML (ArgoUML )and Microsoft VISIO.

 Business Value Add on: Business cases, Business Architecture Analysis, Cost-Time-Benefit Assessments, Risk strategies, Gap Analysis.

 Requirement Elucidation Tools: Brainstorming, Stakeholder Interview, Story Boarding, Workshop, Reverse Engineering, Process Mapping, Observation, Organizational Analysis, Team Analysis etc.

Other Tools: Contour (for requirement management), JIRA (for work backlog and bug backlog tracking), Team Foundation Server (Smartexcel4tfs for requirement traceability), Windchill (for document review) etc.

Techniques: MOST, MoSCoW, SWOT, de Bono's Six Thinking Hats, SCRS, Modified Five Whys.

 Gap Analysis and Quality tools:  Histogram, Scatter diagram, Check sheet, Pareto Chart and Ishikawa diagram etc.

Risk Management

Root Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), Failure Modes,  Effects, and Criticality  Analysis (FMECA), Risk Priority Number (RPN) estimation, Qualitative Fault Tree Analysis (FTA) and FDA’s Human Factor Engineering, CAPA process

Regulatory Compliance

21CFRs (Part11, Part210 and 211, Part820 or Quality System Regulation, Part 807, Part 814 etc.), 520(k)/PMA process, GDMP, and GMP

HIPAA Privacy and Security, PHI, ARRA, HITECH Act, EDI transaction and code sets

HCP Aggregate Spend Reporting, PPACA, Physician’s Sunshine Legislation, CDISC (SDTM and ODM) PhRMA regulations, CRF 42, and US State and Federal regulations (DC and ME).

ISO 9001, ISO 14971, ISO 13485, IEC 62304

Medical Software Development

CRF, CTMS, CDMS, CDARS, Medical Device Software, PMS-EHR and EMR, HCP aggregate spend, and LIMS.

Regulatory Submission

eCTD, regulatory Dossier and Documents, Assisted in IND and NDA submissions

Clinical Data Management

Safety data management, SAE data reconciliation, , Pharmacovigilance (AE reporting), MedDRA V.16, Individual Case Safety Reports (ICSRs) and Common Terminology Criteria for Adverse Events (CTCAE) V4.0

Presales Activities

Support in lead generation, building business proposals and collateral etc., presenting the organization capabilities to prospective customer, attending and presenting at seminars on behalf of the organization.

Used Salesforce for lead management.

Statistical Software

Statistical Programming using SPSS, SAS BASE, MACRO, etc.

EMPLOYMENT SUMMARY

  • Successful track records of turnkey business development, product development, client engagement resulting in profitable project execution/product delivery and high customer satisfaction. Functioned as  Internal and External consultant to provide specialized advice in management, using the wide knowledge of the subject matter
  • Utilized different Agile Methodologies (especially Scrum and Scrumban) and other SDLCs.
  • Elucidated complex scientific requirements into functional requirements. Worked in close liaison with research scientists, statisticians and the IT development team, presales et al. Extensively used System Engineering Concepts for structural modeling and behavioral modeling etc. Worked with a variety of technology platforms such as web, client/server etc. Generated Pseudo Code, Logical Architecture and Mathematical Design. Involved in Solution Design, Proposal DevelopmentRequirement AnalysisGap Analysis, Stakeholder management, Regulatory Compliance, UAT and Go-Live.

  • Managed Pharma operations and related processes. Engaged in Operational Excellence; lift man step to process transformation and introducing business value articulation etc., stakeholder management, performance management, metrics reporting, invoice, escalation, handling SLA and service metrics, employee idea process etc.

  • Gap analysis and process optimization and implementation of improvements. Develop KPIs such as, value add, resource spent / time, dollar spent / time, time to delivery, time to resolve, planned vs. actual delivery using SMART criteria etc.

  • Conducted Quality Reviews, Documentation Reviews etc. Reviewed trial protocols, SOPsCRFsSRS and various product specification documents, design documents etc. Provided a number of Study Reports (CSR) for electronic submissions.Managed risk, monitored, reviewed and implemented compliance, for Healthcare/Pharma products.

  • Established international quality systems and improved organizational standards. 

  • Advised on Hospital Enterprise solutions and US Health Care regulations, US Drug, Medical Device compliances, e-commerce application.

  • Implemented CDISC (SDTM and ODM) standards. Worked in Phases I, II & III of Drug Development Cycle.

  • Established new product lines. Designed and executed Product Evaluation Tests.

Work history

Work History

Globallogic Inc.

Jan 2014 - Present

Consultant II, Subject Matter Expert

  • Investigating & understanding key business issues, existing business models and the data flow and provided clear and timely analysis/recommendations and improvements.
  • Regularly interacting with the customer business team (includes scientists, systems engineers, requirement engineers, architects, designers, developers, testers, project managers, product owners etc.) through stakeholder meeting, workshop, strategic meet up, scrum escalation meeting, requirement review meeting, JAD, Catch up and 1-0-1 pairing to understand stakeholder needs and transform these needs to simplified functional and non-functional business requirements.
  • Supporting operations and related processes. Gap analysis and process optimization and implementation of improvements.
  • Develop KPIs such as, value add, resource spent / time, dollar spent / time, time to delivery, time to resolve, planned vs. actual delivery using SMART criteria etc.
  • Using statistical techniques (quality tools and SPC) to analyze variation and risk.
  • SME advising for the development of Medical Device (Audiological) software for Cochlear Implant and Hearing aids.
  • Creating and defining algorithms and statistical and mathematical calculations for acoustic strategy, mapping, stimuli response and different telemetry etc.
  • Working as a liaison across Business owners and the Delivery team to facilitate successful execution of deliverables.
  • Requirement elucidation, gap analysis, interface analysis, challenge analysis
  • Developing User Stories, SRS, Use Cases, Clinical Parameters, and Business Rules
  • Defining process flows and work flows, wireframes, models, prototypes, activity diagrams, sequence diagrams
  • Managing product risk, creating risk responses (CAPA), conducting Hazard Analysis, authoring different Risk Management files and reports.
  • Handling and resolving CR (Change Request) and non-conformants are according to the industry’s best practices.
  • Reviewing test plans to ensure that all requirements are addressed by the test procedures. Exploratory testing to gain further insight on the system to help VnV to develop effective test plan.
  • Conducting Quality Reviews, Documentation Reviews including SOP reviews. Designing and monitor test cases, user scenarios, test plans etc. Exploratory testing to gain insight on the system and to assist in developing effective test plan.
  • Train and direct the team for domain.
  • Enhancing Healthcare and Medical Device domain competency and providing regulatory compliance guidance.

Mindteck India Ltd., Kolkata

Aug 2011 - Nov 2012

Compliance Specialist

  • Heading the clinical data management group. Establishing a Healthcare Pharma vertical in the organization.
  • Engaged in Operational Excellence; lift man step to process transformation and introducing business value articulation
  • Understanding the pain areas and developing one stop, client specific, enterprise class solutions.
  • Providing Solution Design and Proposal, Requirement Analysis, Risks Management Plan, Gap Analysis, Regulatory Compliance guidance, Pseudo Code, Logical Architecture and Mathematical Design, SME testing and computer system validation etc.
  • Managing stakeholders, performance management, metrics reporting, invoice, escalation, handling SLA and service metrics, employee idea process etc.
  • Defining product lines for Healthcare systems such as M.U (Meaningful Use) compliant Electronic Heath Record Systems (EHR) and Electronic Medical Records systems (EMR), HCP aggregate spend data and reporting system in accordance with evolving Federal and State requirements (DC and ME).
  • Designing Medical Device software such as vital signs monitors and Clinical Trial systems such as CTMS, CDMS, EDC, and CDAR and Laboratory Information Management system (LIMS).
  • Providing compliancy guidance including 21CFR (Part 11, Part820, Part 807, Part 814 etc.), 520(k)/PMA process, GDP, GLP and GMP, EDI transactions and code sets, HIPAA, PHI, PPACA, HCP(O) Aggregate Spend, HITECH, CDISC (SDTM and ODM), ISO 9001, ISO 14971, ISO 13485, IEC 62304
  • Building long term key customer relation, identification of champions, generating future scopes.
  • Defining business scopes and preparing BRD for internal products.
  • Training internal stakeholders on Sunshine Legislation, FDA guidance’s, GxPs, CFRs, ISOs
  • Representing the organization in international seminars and conferences, accepting positions or offices (whether for profit or otherwise) in any trust, firm, society, club, company, corporation or the like on behalf of the organization and training.

Ascendum Solutions Ltd.

Sep 2009 - Aug 2011

Sr Scientific Advisor and Subject Matter Expert

  • Facilitated Functional decomposition of requirements, interface analysis, functional and non-functional requirement review and analysis at various interfaces of project development, documenting requirement risks, analyzing challenges and risks in eliciting requirements.
  • Analyzed business rules, assessing the client, modeling data,  analyzing decisions, analyzing documents. Creating organizational models, scope models and mind maps.
  • Designing risk strategies and creating risk responses.
  • Developing domain specific use cases, business rules, class models and conducting quality assurance testing of measures modules.
  • Train and direct the team for domain specific requirements. Work with developers to create prototypes and review with business users. Assisted the Business Development team in developing scope, capabilities etc. in clinical trial domain. 
  • Reviewed and audited system compliancy with CFR21 regulations  and ICH guidelines. Converted existing raw data into CDISC (SDTM) standards and reviewed SOPs and CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives defined in the protocol.
  • Directing the development of CDMS software for various neurocognitive drug trials. Estimation of CTMS projects, analyzing business rules, assessing the client, modeling data, analyzing decisions, analyzing documents. Creating organizational models, scope models and mind maps.
  • Architected the orchestration framework and the logical design for different neuro-cognitive and neuro-motor clinical trial data management software.
  • Created complete scientific algorithms, statistical and mathematical calculations for different modules for a big CDMS system and helped project architects in developing compliant process definition and flows. Rendered business knowledge and scientific concepts related to clinical software development. 
  • Creating and defining algorithms and statistical and mathematical calculations for different measure modules such as subject mapping, response randomization, stimuli sequencing etc.

TAKE Enterprise Services, Inc

Oct 2008 - Sep 2009

Systems Analyst

  • Managing Enterprise solutions for hospitals that connects different client data systems such as EMR and EHR.
  • Implemented HIPAA policies.
  • Review and approval for regulatory dossier and documents.

University Of Tennessee, Knoxville

Aug 2004 - Oct 2008

Graduate Teaching Assistant

  • Taught graduate (MS) and undergraduate (BS) level Pharmacodynamics, Pharmacovigilance, Bioinformatics, Genetics and Molecular Cell Biology
  • Involved in making and grading of quizzes, projects, and exams, group reviews etc.
  • Managed the laboratory resources, assisted in GTA weekly meetings and seminars
  • Conducted various student projects and advised for Master’s and Bachelor’s dissertation.

Karmanos Cancer Institute - University of Tennessee

Jan 2008 - Oct 2008

Statistical Analyst

I assisted in projects which were associated with the investigational drugs of oncology segment. I was involved in the processing of data from phase I, II and III of clinical trials and generating TLG’s according to the specifications. I was also involved in developing and management of regulatory submission documents to FDA and other controlling agencies.

Oak Ridge National Laboratory-University of Tennessee

Aug 2004 - Oct 2008

Graduate Research Assistant

Each cell communicates with another cell or environment by a process called signal transduction. This is the key for many pathways of expression of life.

The signaling in cell occurs by the help of surface signal receptor proteins. GPCRs are one of such proteins. GPCRs work in “lock and key” relation with specific ligand molecules. Those ligands bind to specific facets of GPCRs and this binding creates structural changes in the GPCR protein which initiates arrays of different pathways inside the cell. One of these pathways results in pancreatic cancer. We have taken human pancreatic cell lines and modified the GPCRs structure by introducing nanobots that bound to specific portions of the protein and changed structure of the latter. These structural changes resulted in decreasing the cell proliferative effect.

Medtronic, TN, US

Aug 2004 - Sep 2005

SAS Programmer

I was involved in the extraction and analysis of clinical trials data, generation of graphs, listings, and reports that supported the statistical and medical writing.

Magus Systems Pvt

Apr 2002 - Jul 2004

Business Process Analyst

  • Managing project for one of the earliest e-commerce application (DreamHobbys).

Education

Education

Oak Ridge National Laboratory-University of Tennessee

Aug 2004 - Dec 2008

PHD Doctorate (awaiting certification)

University of Tennessee

Sep 2004 - Aug 2008

M.S in Genome Sciences, Bioinformatics and Statistics

Stanford University

Aug 2005 - Jan 2006

Diploma in Applied Mathematics

University of Tennessee

Jan 2005 - Aug 2005

Diploma in Military Tactics and Planning

Calcutta University

Mar 2002 - Jan 2004

M.A in English Literature (Distance Learning)

Bhopal University

Mar 2000 - Dec 2002

M.Sc in Microbiology

Calcutta University

Mar 1995 - Mar 1999

B.Sc in Botany (Hons), Zoolgy, Chemistry,

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